
[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]               
[Page 46441-46442]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0410]

 
Request for Notification from Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representatives on Medical Device Advisory Committee Panels and Request 
for Nonvoting Industry Representatives on Medical Device Advisory 
Committee Panels

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is requesting that any 
industry organization interested in participating in the selection of 
nonvoting industry representatives to serve on certain device panels of 
the Medical Devices Advisory Committee in the Center for Devices and 
Radiological Health notify FDA in writing. A nominee may either be 
self-nominated or nominated by an organization to serve as a nonvoting 
industry representative. Nominations will be accepted for current 
vacancies effective with this notice.

DATES: Any industry organizations interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by October 9, 
2009, for the vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by October 
9, 2009.

ADDRESSES:  Send all letters of interest and nominations to Kathleen L. 
Walker (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5238, Silver Spring, MD 20993, 301-796-
5964, e-mail: kathleen.walker@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Section 520(f)(3) of the Federal Food, Drug, 
and

[[Page 46442]]

Cosmetic Act (the act) (21 U.S.C. 360j(f)(3)), as amended by the 
Medical Device Amendments of 1976, provides that each medical device 
panel include one nonvoting member to represent the interests of the 
medical device manufacturing industry.
    FDA is requesting nominations for nonvoting members representing 
industry interests for the following vacancies listed in table 1 of 
this document.

                                                    Table 1.
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                           Medical Devices Panels                                  Approximate Date Needed
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Dental Products Panel                                                        November 1, 2009
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General Hospital and Personal Use Devices Panel                              January 1, 2010
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Hematology and Pathology Devices Panel                                       March 1, 2010
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Immunology Devices Panel                                                     March 1, 2010
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Ophthalmic Devices Panel                                                     November 1, 2009
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I. Functions

    The functions of the medical device panels are listed as follows: 
(1) Review and evaluate data on the safety and effectiveness of 
marketed and investigational devices and make recommendations for their 
regulation, (2) advise the Commissioner of Food and Drugs regarding 
recommended classification or reclassification of these devices into 
one of three regulatory categories, (3) advise on any possible risks to 
health associated with the use of devices, (4) advise on formulation of 
product development protocols, (5) review premarket approval 
applications for medical devices, (6) review guidelines and guidance 
documents, (7) recommend exemption to certain devices from the 
application of portions of the act, (8) advise on the necessity to ban 
a device, (9) respond to requests from the agency to review and make 
recommendations on specific issues or problems concerning the safety 
and effectiveness of devices, and (10) make recommendations on the 
quality in the design of clinical studies regarding the safety and 
effectiveness of marketed and investigational devices.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the contact 
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of 
publication of this notice. Within the subsequent 30 days, FDA will 
send a letter to each organization that has expressed an interest, 
attaching a complete list of all such organizations, and a list of all 
nominees along with their current resumes. The letter will also state 
that it is the responsibility of the interested organizations to confer 
with one another and to select a candidate, within 60 days after the 
receipt of the FDA letter, to serve as the nonvoting member to 
represent industry interests for a particular device panel. The 
interested organizations are not bound by the list of nominees in 
selecting a candidate. However, if no individual is selected within the 
60 days, the Commissioner of Food and Drugs will select the nonvoting 
member to represent industry interests.

III. Qualifications

    Persons nominated for the device panels should be full time 
employees of firms that manufacture products that would come before the 
panel, or consulting firms that represent manufacturers, or have 
similar appropriate ties to industry.

IV. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Within the 30 days, the following information should be 
sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT): A 
current curriculum vitae of each nominee, current business and/or home 
address, telephone number, e-mail address, and the name of the device 
panel of interest. FDA will forward all nominations to the 
organizations expressing interest in participating in the selection 
process for the device panel. (Persons who nominate themselves as 
nonvoting industry representatives will not participate in the 
selection process).
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees, and therefore, 
encourages nominations for appropriately qualified candidates from 
these groups.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21555 Filed 9-8-09; 8:45 am]

BILLING CODE 4160-01-S
